Braftovi 75 mg capsule

Generic name:
Encorafenib - oral

Pronunciation
(EN-koe-RAF-e-nib)

Brand name(s)
Braftovi

Encorafenib is used to treat certain types of cancer (such as lung cancer, melanoma skin cancer, cancer in the colon or rectum). Encorafenib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Read the Medication Guide provided by your pharmacist before you start taking encorafenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

If you vomit after taking a dose, do not take another dose at that time. Take your next dose at the regular time.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Nausea, vomiting, diarrhea, headache, tiredness, abdominal pain, joint pain or swelling, dry/itching skin, constipation, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return if treatment is stopped.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising (such as bleeding of the gums)
• black/bloody stools
• vomit that contains blood or looks like coffee grounds
• vision changes (such as blurred vision, decreased vision, seeing halos/colored dots)
• signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

Although this medication is used to treat certain skin cancers, it may rarely cause new skin or other cancers. Tell your doctor right away if you notice unusual skin changes (such as skin sores/lumps, warts, change in the size/color of a mole). Your doctor should check your skin before starting treatment, every 2 months during treatment, and for up to 6 months after stopping this medication.

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting
• signs of bleeding in the brain (such as severe headache, weakness on one side of the body, sudden vision changes, trouble speaking, seizures, confusion)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking encorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems
• eye problems
• liver problems

This drug may make you dizzy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Encorafenib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using encorafenib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using encorafenib safely.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using encorafenib. Encorafenib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication and for 2 weeks after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of encorafenib from your body, which may affect how encorafenib works. Examples include azole antifungals (such as itraconazole, ketoconazole), certain HIV protease inhibitors (such as atazanavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include doravirine, elagolix, elbasvir, etravirine, grazoprevir, lenacapavir, lurasidone, nisoldipine, praziquantel, ranolazine, rilpivirine, tamoxifen, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as heart/liver function, skin/eye exams, complete blood count) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is within 12 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.